, Feb. 11, 2014
/PRNewswire/ -- NeuroSigma, Inc. (NeuroSigma), a California
-based life sciences company focused on commercialization of its non-invasive Monarch eTNS System
for the treatment of neurological and neuropsychiatric disorders, announced the appointment of Carl Adams
as Vice President and Controller.
Mr. Adams brings 20 years of experience in accounting and corporate finance to NeuroSigma. After nine years at Ernst and Young LLP, culminating as a Senior Manager in the firm's audit practice, Mr. Adams joined Amgen, Inc. While at Amgen he served as a Senior Manager, Assistant Director and Director for SEC Reporting and Corporate Accounting. He was responsible for SEC reporting, commercial accounting, research and development accounting and technical accounting matters in all areas affecting Amgen, as well as Sarbanes Oxley compliance relating to internal controls over financial reporting. He later became a co-founder and partner of TAC Solutions LLC, a provider of advisory services in financial reporting, complex accounting matters, audit preparation and support, and accounting policies and procedures. Mr. Adams graduated from California State University, Northridge, and obtained his Certified Public Accountant (CPA) license in California.
"Carl brings extensive financial experience in the life sciences industry to NeuroSigma and we are delighted that he has joined our management team," said Leon Ekchian, Ph.D., President & CEO of NeuroSigma.
Background The Monarch eTNS System from NeuroSigma
In August 2012, NeuroSigma received CE Mark approval to market NeuroSigma's first TNS product, the Monarch eTNS System in the European Union, for the adjunctive treatment of drug-resistant epilepsy (DRE) and major depressive disorder (MDD) for adults and children 9 years and older. In addition, the Monarch eTNS System also received a Class II medical device license from Health Canada in April of 2013 allowing NeuroSigma to market the system for treatment of DRE and MDD for adults and children 9 years and older. NeuroSigma is currently offering the Monarch eTNS System to patients in the European Union and Canada with a physician's prescription.
The Monarch eTNS System is composed of a cell-phone sized pulse generator and a single-use patch that is applied to the forehead. Signals are transmitted through lead wires to the patch in order to stimulate the trigeminal nerve in the skin of the forehead; triggering these nerve fibers sends signals to targeted brain regions and changes the activity there. Patients may conveniently self-administer the Monarch eTNS System at home and typically use the device while sleeping.
The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain, bilaterally and at high frequency. The trigeminal nerve projects to specific areas of the brain, such as the locus coeruleus, nucleus tractus solitarius, thalamus and the cerebral cortex, which are involved in epilepsy, depression, PTSD, ADHD and other disorders.
Trigeminal Nerve Stimulation (TNS) is the electrical stimulation of branches of the trigeminal nerve, which are located near the surface of the forehead. Functional neuroimaging data suggests the mechanism of action of TNS is related to its ability to modulate activity in targeted brain regions.
CAUTION: In the United States, eTNS is an investigational device and is limited by Federal law to investigational use. The U.S. Food and Drug Administration has given NeuroSigma approval to proceed with a pivotal Phase 3 clinical trial of eTNS in drug resistant epilepsy. Completion of that Phase 3 study is necessary before the FDA will consider permitting the marketing and sale of eTNS in the United States.
eTNS, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc.
About NeuroSigma, Inc.
NeuroSigma is a Los Angeles-based life sciences company established to develop TNS technologies with the potential to transform medical practice and patients' lives. NeuroSigma is focused on TNS neuromodulation therapies based on intellectual property licensed on an exclusive basis from the University of California, Los Angeles (UCLA), including TNS therapies for epilepsy, depression, post-traumatic stress disorder (PTSD) and attention-deficit hyperactivity disorder (ADHD). For more information about NeuroSigma, please visit www.neurosigma.com
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements, including but not limited to, research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding our eTNS system. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new medical device products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations.
SOURCE NeuroSigma, Inc.